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Quality of Life of Adult Cancer Survivors Who Have Undergone a Previous Bone Marrow or Peripheral Stem Cell Transplant for a Childhood Hematologic Cancer

Primary Purpose

Leukemia, Lymphoma, Myelodysplastic Syndromes

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
cognitive assessment
management of therapy complications
psychosocial assessment and care
quality-of-life assessment
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Leukemia focused on measuring quality of life, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, juvenile myelomonocytic leukemia, childhood Hodgkin lymphoma, childhood lymphoblastic lymphoma, childhood large cell lymphoma, childhood small noncleaved cell lymphoma, childhood acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood chronic myelogenous leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Case group Previously treated with an allogeneic, unrelated, syngeneic, or autologous bone marrow or peripheral blood stem cell transplantation for a hematologic malignancy ≥ 5 years ago while enrolled on 1 of the following protocols: FHCRC-160.06 FHCRC-179.07T FHCRC-446.03T FHCRC-661.04 FHCRC-697.00 FHCRC-796.00 FHCRC-843.00 Disease-free survivor Under 18 years of age at time of transplantation Any prior preparative regimen allowed Control group Sex-matched sibling within 5 years of patient's age* No chronic illnesses (e.g., cancer, diabetes, or asthma) that require medication No allergies that limit physical activity NOTE: *If such a sibling is not available, but another sibling is available, then that sibling would be asked to nominate a friend or relative of the same gender as the patient who is also within 5 years of the patient's age; the patient must consent in order for the control subject to participate PATIENT CHARACTERISTICS: Age See Disease Characteristics 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Must be able to speak, read, and write English PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Neuroendocrine status of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18
Cognitive capability of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18
Physical capability of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18
Psychosocial status of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18

Secondary Outcome Measures

Full Information

First Posted
August 2, 2005
Last Updated
April 29, 2013
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00126477
Brief Title
Quality of Life of Adult Cancer Survivors Who Have Undergone a Previous Bone Marrow or Peripheral Stem Cell Transplant for a Childhood Hematologic Cancer
Official Title
The Quality of Life of Adult Survivors Who Received a Marrow Transplant as a Child
Study Type
Observational

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 1996 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Studying quality of life in cancer survivors may help determine the long-term effects of hematologic cancer and may help improve the quality of life for future cancer survivors. PURPOSE: This clinical trial is studying the quality of life of adult cancer survivors who have undergone a previous bone marrow or peripheral stem cell transplant for a childhood hematologic cancer.
Detailed Description
OBJECTIVES: Determine the extent to which adult cancer survivors who have undergone prior bone marrow or peripheral blood stem cell transplantation for a pediatric hematologic malignancy require ongoing health care and whether these needs change with increasing time after transplantation. Correlate physical capabilities, body image, physical limitations, including sexuality issues which alter or influence lifestyle, with time after transplantation in these patients. Determine whether cognitive abilities relative to memory and neurobehavioral ratings change with increasing time after transplantation in these patients. Correlate social and relationship abilities with length of time after transplantation in these patients. OUTLINE: Patients and siblings complete a self-report quality of life questionnaire, including outcome assessments of neuroendocrine function, cognitive abilities, physical capability, and psychosocial behavior. PROJECTED ACCRUAL: Approximately 750 patients (375 adult cancer survivors [case group] and 375 siblings [control group]) will be accrued for this study within 7 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Myelodysplastic Syndromes, Quality of Life
Keywords
quality of life, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, juvenile myelomonocytic leukemia, childhood Hodgkin lymphoma, childhood lymphoblastic lymphoma, childhood large cell lymphoma, childhood small noncleaved cell lymphoma, childhood acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood chronic myelogenous leukemia

7. Study Design

Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
cognitive assessment
Intervention Type
Procedure
Intervention Name(s)
management of therapy complications
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Neuroendocrine status of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18
Title
Cognitive capability of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18
Title
Physical capability of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18
Title
Psychosocial status of disease-free childhood transplant patients at 5 years after transplant and ≥ age 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Case group Previously treated with an allogeneic, unrelated, syngeneic, or autologous bone marrow or peripheral blood stem cell transplantation for a hematologic malignancy ≥ 5 years ago while enrolled on 1 of the following protocols: FHCRC-160.06 FHCRC-179.07T FHCRC-446.03T FHCRC-661.04 FHCRC-697.00 FHCRC-796.00 FHCRC-843.00 Disease-free survivor Under 18 years of age at time of transplantation Any prior preparative regimen allowed Control group Sex-matched sibling within 5 years of patient's age* No chronic illnesses (e.g., cancer, diabetes, or asthma) that require medication No allergies that limit physical activity NOTE: *If such a sibling is not available, but another sibling is available, then that sibling would be asked to nominate a friend or relative of the same gender as the patient who is also within 5 years of the patient's age; the patient must consent in order for the control subject to participate PATIENT CHARACTERISTICS: Age See Disease Characteristics 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Must be able to speak, read, and write English PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean E. Sanders, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Quality of Life of Adult Cancer Survivors Who Have Undergone a Previous Bone Marrow or Peripheral Stem Cell Transplant for a Childhood Hematologic Cancer

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